VIRTUAL INSPECTION

VIRTUAL INSPECTION PURPOSE: To lay down the procedure for establishing a comprehensive system of virtual inspection in order to determine the effectiveness of the systems, system compliance and to identify the opportunities for continual improvement as per current regulatory requirements. SCOPE: This SOP is applicable for conducting virtual inspection of all Manufacturing/Analytical sites of Vendors, … Read more

AUDIT OBSERVATIONS

AUDIT POINT Warehouse: Pictorial presentation not available in sampling change room (Minor) Manufacturer released /approved label not defaced (Minor) Policy for usage of raw materials having retest date claim by manufacturer not defined in in SOP (Minor) Dispensing scoop status label not available of cleaned on, previous product, Use up to Most of the tools … Read more

VERIFICATION AND TESTING OF FINISHED GOODS

VERIFICATION AND TESTING OF FINISHED GOODS PURPOSE: To provide the procedure for testing of finished Goods at outside laboratory and physical verification to ensure that product is complies with specification criteria. SCOPE: This Procedure is applicable for finished product testing at outside lab and receive at depot. Procedure for Physical verification of finished product is … Read more

In-process checks during Dry powder injection manufacturing & packing (IPQA)

In-process checks during Dry powder injection manufacturing & packing (IPQA) Objective: : To lay down a procedure for in process checks during Dry powder injection manufacturing & packing. Scope: This procedure is applicable to formulation Plant of pharmaceutical Industry for in process checks during Dry powder injection manufacturing & packing. Responsibility: IPQA Officer/Executive shall be responsible … Read more

Liquid Bourne Particle counter (LBPC)

Liquid Bourne Particle counter (LBPC) Objective: To lay down the procedure for Cleaning, Operation, Maintenance, and Analysis of samples using LBP counter. Scope: This SOP is applicable for the Operation, Cleaning, Maintenance and Analysis of LBPC samples in the manufacturing department. Responsibility: Microbiologist / IPQA personnel are responsible for follow the procedure. Accountability: Head – Quality Assurance … Read more

PROCEDURE FOR AGREEMENT/QUALIFICATION OF EXTERNAL VALIDATION AGENCIES/SERVICES PROVIDERS/PARTIES

VALIDATION: PROCEDURE FOR AGREEMENT/QUALIFICATION OF EXTERNAL VALIDATION AGENCIES/SERVICES PROVIDERS/PARTIES The purpose of this SOP is to lay down procedure for selection Qualification and approval of Service Providers for Outsourced activities of manufacturing sites  This procedure shall be applicable for approving, controlling and reviewing of Service Providers supporting outsourced activities relevant to cGMP systems covered as … Read more

INVESTIGATIONS SOP 

INVESTIGATIONS SOP  This Standard Operating Procedure (SOP) defines the requirements for reporting, documenting, investigating, evaluating, managing, resolving and approving closure of investigations from cGxP, approved specifications and/or procedures. This standard applies to Investigations related to quality related events that occur from cGxP, approved specifications, and/or procedures including but not limited to Protocols, Master Batch Records … Read more

Alcoa++

Alcoa++ In a world where data plays a crucial role in decision-making and technological advancements shape various industries, the significance of data integrity cannot be emphasized enough. Alcoa, a company renowned for its commitment to excellence, extends the principles of Alcoa Plus Plus beyond aluminum production to prioritize data integrity as a fundamental aspect of … Read more

Introduction of New Product in Facility

Introduction of New Product in Facility The implementation of a novel product in a pharmaceutical industries necessitates a Carefully planned & organized sequence of actions to guarantee a seamless and adheres to regulations and guidelines. Below is an exhaustive compilation of activities that should be taken into account: New Product Project Planning: Create a project plan … Read more

Clean Room Quiz 6

Quiz

Clean Room Quiz 6 Question: What is the purpose of an airflow direction test and visualization? Answer: The purpose of an airflow direction test and visualization is to demonstrate that the airflow direction and its uniformity of velocity conform to the design and performance specifications. Question: What are the four methods used for performing the … Read more

Clean Room Quiz 5

Quiz

Clean Room Quiz 5 Question: What is recommended for measuring the supply air volume flow rate in cases where there is local airflow turbulence and jet velocities issuing from an outlet? Answer: It is recommended to use an airflow capture hood that captures all of the air issuing from each final filter or supply diffuser. … Read more

Clean Room Quiz 3

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Clean Room Quiz 3 Question: When need to plan for testing and verification testing should be conducted according to the ISO 14644? Answer: Testing should be carried out at minimum during the following instances: a) In connection with classification according to ISO 14644-1; b) At verification during start-up; c) At verification after failures have been … Read more

Clean Room Quiz 2

Clean Room Quiz 2 Question: What is the objective of the air pressure difference test.? Answer: The objective of the air pressure difference test is to confirm the effectiveness of the cleanroom’s air movement system in maintaining the designated pressure differential between the cleanroom and its surrounding environment. Question: When should the air pressure difference … Read more

Clean Room Quiz 1

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Clean Room Quiz 1 -Question & answers on Clean Room Question: What is the definition of an “airborne particle”? Answer: An airborne particle is described as a solid or liquid object suspended in the air, whether viable or non-viable, falling within a size range spanning from 1 nanometer (nm) to 100 micrometers (μm). Question: How … Read more

Total Quality Management Practices

Total Quality Management Practices Total Quality Management Practices (TQMS) the first thing that comes to mind when you think of the word “quality”? The word “quality” has many definitions. Quality can be defined as a characteristic or characteristic, as in the following statement: “They are honest people, and that is a good quality.” They also ask … Read more

GxP in Pharmaceuticals: Ensuring Quality, Safety, and Compliance

GxP in Pharmaceuticals: Ensuring Quality, Safety, and Compliance To lay down a procedure for good documentation practices requirements for the compliant, consistent and accurate completion of GxP Documentation. GxP in Pharmaceuticals This Procedure applies to all cGxP documents (electronic and handwritten) used in the manufacturing, packaging, labelling, testing, storage and distribution of Drug Products and … Read more

Assigning Manufacturing and Expiry date to the Finished Products

Assigning Manufacturing and Expiry date to the Finished Products Objective To lay down a procedure for assigning manufacturing and expiry dates to the finished products manufactured. Scope This procedure shall apply to all products manufactured. Responsibility Executive / Officer Production shall be responsible for assigning manufacturing and expiry dates to batches of finished product Head, … Read more

Internal Audit and Self Inspection

Internal Audit and Self Inspection Internal Audit: An onsite verification of activity used to determine effective implementation of documented quality systems. Self-Inspection : Verification of departmental activity used to determine effective implementation of documented quality systems. Objective To lay down a procedure for periodic internal audit and self inspection, to ensure current Good Manufacturing Practices … Read more

Preparation, Approval, Review and Control of Technical Directions for Manufacture of Drug Products

Preparation, Approval, Review, and Control of Technical Directions for the Manufacture of Drug Products Objective To lay down a procedure for the Preparation, Approval, Review, and Control of Technical Directions for Manufacture of Drug Products. Scope This Standard Operating Procedure is applicable for the preparation and implementation of Technical Directions for all products manufactured at … Read more

HOLD TIME STUDY FOR DISPENSED MATERIAL, INTERMEDIATES AND FINISHED PRODUCTS

HOLD TIME FOR DISPENSED MATERIAL, INTERMEDIATES  AND FINISHED PRODUCTS The purpose of this SOP is to describe the systematic procedure to establish the hold time of Dispensed materials, intermediate and bulk product prior to final packing. This SOP is applicable for Dispensed materials, intermediate as well as bulk product hold time study. REFERENCE(S) & ATTACHMENT(S) … Read more